RecruitingNot Applicable

Transcutaneous Spinal Cord Stimulation Home Study

Canada6 participantsStarted 2024-02-15

Plain-language summary

The goal of this pilot clinical trial is to examine the safety and feasibility of SCONE as home based therapy for orthostatic hypotension and bowel dysfunction in individuals with spinal cord injury or multiple system atrophy. The main aims of the study are: * To establish a safe protocol for home-based transcutaneous spinal cord stimulation therapy at the research centre * To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction Participation will last approximately 10 weeks (excluding screening period) and involves * Attending the study center to collect baseline evaluations and to plan where electrodes will be placed * A 2 week treatment period at the centre with 3 visits per week * A 6 week home based therapy period involving 1 hour treatments twice a day * Attending the study center to collect post-treatment evaluations

Who can participate

Age range19 Years – 70 Years

SexALL

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Inclusion criteria

✓. Resident of British Columbia, Canada with active provincial medical services plan
✓. Male or female, 19-70 years of age The safety and feasibility of home-based non-invasive spinal cord stimulation for orthostatic hypotension in individuals with severe autonomic dysfunctions (H23-00192) Protocol Version 1.0, December 8, 2023 Page 6 of 23
✓. Chronic spinal cord injury (SCI) (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR Multiple System Atrophy (MSA) of the parkinsonian type.
✓. \>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
✓. American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH (Orthostatic Hypotension) for MSA.
✓. Willing and able to comply with all clinic visits and study-related procedures.
✓. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
✓. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.

Exclusion criteria

What they're measuring

Systolic blood pressure (SBP) changes in millimeters of mercury (mmHg) during TSCS

Timeframe: 6 weeks

Blood pressure (BP) changes in millimeters of mercury (mmHg) in 24-hrs

Timeframe: 6 weeks

Trial details

NCT IDNCT06838637

SponsorMichael Berger

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Andrea Maharaj, BSc

604-675-8856 amaharaj@icord.org

View on ClinicalTrials.gov More Spinal Cord Injuries trials